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Hospital for Special Surgery Hip Arthroplasty Cohort

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ClinicalTrials.gov Identifier: NCT00454506
Recruitment Status : Active, not recruiting
First Posted : March 30, 2007
Last Update Posted : May 25, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes. Most health related quality of life studies in THA and TKA only report data up to twelve months post-operatively. In addition, most large studies of TKA and THA have been performed in Medicare patients. While these databases are important in providing population based data, Medicare studies do not permit any direct patient contact, and provide no information on patients under 65.

Existing studies have also investigated predictors of patient outcome at one and two years after joint arthroplasty. However, very little is known about predictors of prosthesis failure, and there are no validated clinical indicators for choosing one prosthesis model over another. Once a device is FDA approved, there is very little motivation on the part of the developer to perform complete post-marketing research, despite the importance of these data to the public health. Most existent studies are not powered to compare differences between models.

The purpose of this study is to establish a prospective cohort of HSS total hip arthroplasty.

Condition or disease
Hip Arthroplasty

Study Design

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Hip Arthroplasty Cohort
Study Start Date : April 2007
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2027
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will be asking all patients undergoing a total hip arthroplasty to participate.

Inclusion Criteria:

  • 18 years or older
  • Undergoing total knee arthroplasty at HSS
  • Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

Exclusion Criteria:

  • No other exclusion criteria;this is a non-interventional study which only involves filling out questionnaires.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454506

United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Thomas P Sculco, MD Hospital for Special Surgery, New York
More Information

Additional Information:
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00454506     History of Changes
Other Study ID Numbers: 26131
First Posted: March 30, 2007    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017